Pancreatic AdenocarcinomaPhase 2/3NCT05268692
Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP
A Phase 2/3 study testing GS and GnP in people with Pancreatic Adenocarcinoma, run by Kochi University at 1 site in Japan.
Trial summary
The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- GS and GnP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2019to 31 Dec 2030
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective pancreatectomy for pancreatic cancer
Who cannot join
- a previous cancer surgery a body weight loss of >10% during the 6 months before surgery the presence of distant metastases seriously impaired function of vital organs because of respiratory, renal, or heart disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Takehiro Okabayashi
Kochi, 781-8555
Takehiro Okabayashi, +81- 88-837-3000, tokabaya@gmail.com
About this study
Official title: Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP
The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.
Read the detailed description
gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- GS, GnP
- Keywords
- Neoadjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSDrug
drip infusion of gemcitabine plus oral administration of S-1 S-1 received S-1 orally twice daily at a dose calculated according to body-surface area (BSA) (< 1.25 m2, 60 mg/d; ≥ 1.25 to < 1.5 m2, 80 mg/d; ≥ 1.5 m2, 100 mg/d) on days 1 through 14 of a 21-day cycle gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1 and 8of a 21-day cycle.
GnPDrug
drip infusion of both gemcitabine and nab-paclitacel gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
nab-paclitaxel received nab-paclitaxel intravenously at a dose of 100 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| GS | Active comparator | gemcitabine plus S-1 Receives: Drug: GS |
| GnP | Active comparator | gemcitabine plus nab-paclitaxel Receives: Drug: GnP |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
postoperative survival
Measured: 5 years
Secondary outcomes (1)
adverse events
incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takehiro Okabayashi, Kochi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268692
- Sponsor's protocol ID
- GSGnP
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No